Rex Bionics PLC Positive Update from Rapper II Clinical Trial

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Rex Bionics PLC

07 November 2016

Rex Bionics Plc

("Rex Bionics" or the "Company")

REX Clinical Trial shows potential for improved sleep for patients with Spinal Cord Injury

   --     Quality of Life Analysis presented at ACRM conference in Chicago 
   --     Six out of eight sleep indicators show improvement after a single treatment 
   --     Equivalent results between paraplegic and quadriplegic volunteers 

7th November 2016: Rex Bionics Plc (AIM: RXB), the pioneer of the REX Robot technology that enhances the mobility of wheelchair users, is pleased to announce positive results from a final analysis of its RAPPER II clinical trial. RAPPER II is multi-centre, international trial to evaluate the feasibility and safety of the REX and of a set of customised exercises performed in a REX; and the impact on quality of life.

The results were presented by Principal Physiotherapy Investigator, Jon Graham BA, MSc, MSCP at the 93(rd) annual meeting of the American Congress of Rehabilitation Medicine, Chicago Ill.

The analysis focused on the sleep questionnaire, with responses collected before and after a single treatment with REX. In six out of the eight statements, the responses indicated an improvement in sleep reduction, suggesting a beneficial exercise-induced fatigue. The greatest improvement was seen in relation to the proposition "I felt physically tense at night", where there was a 90% improvement in the mean score of all respondents. The next greatest improvements were seen in "I had trouble stopping my thoughts at bed-time"; and "Pain woke me up".

The trial's 18 tetraplegic patients achieved essentially the same results as the 38 paraplegic patients. This confirms that the benefits of the REX technology are available to people with more severe injuries - including those in the upper to mid cervical range in the spinal column. No clear trends were discernible in the pain and spasticity questionnaires that were also used. These questionnaires will be used again in future trials, where there will be not just a single treatment, as in RAPPER II with its focus on safety and feasibility, but with a full course of REX treatment with a therapeutically meaningful frequency and duration. 94% of the volunteers questioned said they would like to use REX on a weekly basis.

The investigators agreed in August 2016, that in view of the strength and clarity of the data, recruitment to the trial should be closed. The final step for RAPPER II is the publication of the trial results in a peer-reviewed journal, expected in 2017.

The next phase of the REX clinical strategy has two elements - the design of a trial in spinal cord medicine to show that REX has a significant and cost-justifiable medical benefit when used in a prescribed course of treatment; and the establishment of trials in other indications, for example - Multiple Sclerosis and Muscular Dystrophy. A trial was recently initiated in Australia for patients with stroke and traumatic brain injury.

Rex Bionics' mission is to establish Robot-Assisted Physiotherapy - in the clinic and at home - as a Standard of Care for people with neurological injury or illness.

Nick Birch, FRCS (Orth), the Principal Investigator of the trial, commented: "The many patients with neurological injury and illness who experience sleep deprivation as a result of pain, will be very encouraged by these results."

Crispin Simon, Chief Executive of Rex Bionics plc added: "RAPPER II has gone according to plan. We have strong safety and usability results; and trends in the quality of life data that are consistent with the positive feedback that we get from patients."

A copy of this announcement has been posted on the Company's website at www.rexbionics.com/.

For further information please contact:

Rex Bionics Plc

Crispin Simon, Chief Executive Officer

[phone]

Peter Worrall, Chief Financial Officer

[phone]

Stifel Nicolaus Europe Limited (NOMAD and Broker)

Jonathan Senior/ Stewart Wallace / Ben Maddison

[phone]

Consilium Strategic Communications

Mary-Jane Elliott / Chris Welsh

[e-mail]

[phone]

About Rapper II

RAPPER II (Robot-Assisted Physiotherapy Exercises with REX) is a trial to evaluate the feasibility and safety of the REX and of a set of customised exercises performed in a REX; and to collect preliminary data on the impact on quality of life.

The trial entails a single visit to the REX clinic, consisting of a walk test and a set of exercises, with feasibility and safety recorded during the visit; and, for the final cohort of volunteers, quality-of-life measures and further safety recorded at two-day or seven-day follow-up.

Six clinics in three countries have participated in the trial: in the UK, Physiofunction Ltd at the Chris Moody Centre, near Northampton; the Royal National Orthopaedic Hospital NHS Trust, Stanmore; and East Kent Hospitals University NHS Foundation Trust, Canterbury; in Australia at Austin Health: Royal Talbot Rehabilitation Centre, Melbourne; and in New Zealand at the Auckland University of Technology; and the Burwood Academy of Independent Living, Christchurch.

The trial was not designed with a specific regulatory focus as REX is already registered for use in the EU, the US and many other parts of the world. The trial is monitored by an independent Clinical Research Organisation. Details can be found at: https://clinicaltrials.gov/show/NCT02417532 .

Data from the first interim analysis of 20 volunteers were presented by Dr Andrew Nunn MBBS, FAFRM (RACP), Medical Director, Victorian Spinal Cord Service, Austin Health: Royal Talbot Rehabilitation Centre, Melbourne, Australia, at the Australian and New Zealand Spinal Cord Society (ANZSCoS) Annual Meeting, Perth, Western Australia on 27 November, 2015.

Data from the second interim analysis were presented in August 2016 at the US Military Health System Research Symposium and showed that REX can safely be used by people with spinal cord injury. 52 out of 56 volunteers (93%) were able to complete the transfer-walk-exercise protocol ("Treatment Success") - the primary endpoint of the trial. There were no Serious Adverse Events.

About Rex Bionics Plc

Rex Bionics is the pioneer of the "REX" that provides robotic standing, walking and exercise support for wheelchair users; and was founded by two British engineers with first-hand experience of the needs of wheelchair users. REX is used by people who have suffered a spinal cord injury, stroke or other traumatic brain injury; and people with multiple sclerosis, muscular dystrophy and cerebral palsy.

We are working with physiotherapists to develop the concept and practice of Robot-Assisted Physiotherapy (RAP); and also offer REX P, for use in the home, enabling customers to walk and stand with their hands free - providing more work and recreation options.

Wheelchair users are at risk of developing numerous medical complications from extended periods of sitting. By enabling them to spend more time standing, walking and exercising, REX may offer significant health benefits, including improved sleep and maintenance of joint range, and a reduction in spasm, pain, common abdominal problems and prescription drug use.

Our commitment to engineering excellence is complemented by a commitment to clinical science and the RAPPER II clinical trial results show high levels of practicality, safety and user enthusiasm.

Our Vision is that every day, around the world, thousands of people get relief with REX, from the harm - the pain, discomfort and inconvenience - of neurological accidents and illnesses; and that many will be cured.

This information is provided by RNS

The company news service from the London Stock Exchange

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November 07, 2016 04:47 ET (09:47 GMT)